PATIENT PACKAGE INSERT

What should I tell my healthcare provider before using this medicine?

take any other medicines, especially ones commonly called TZDs (thiazolidinediones).

What are the possible side effects?

This medicine can cause serious side effects, including:

Heart Failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with this medicine may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs.

Your healthcare provider should monitor you closely while you are taking TZDs with this medicine. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:

shortness of breath

swelling of your ankles or feet

sudden weight gain

Treatment with TZDs and this medicine may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

WARNINGS AND PRECAUTIONS

Fluid retention and heart failure with concomitant use of PPAR-gamma agonists:

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

PATIENT PACKAGE INSERT

What should I tell my healthcare provider before using this medicine?

Tell your healthcare provider if you:

take any other medicines, especially ones commonly called TZDs (thiazolidinediones).

What are the possible side effects?

This medicine can cause serious side effects, including:

Heart Failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with this medicine may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs. Your healthcare provider should monitor you closely while you are taking TZDs with this medicine. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:

shortness of breath

swelling of your ankles or feet

sudden weight gain

Treatment with TZDs and this medicine may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

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